New combo aims to save esophagus in advanced cancer patients
NCT ID NCT07622797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining the immunotherapy drug camrelizumab with chemotherapy and radiation can shrink advanced esophageal cancer enough to avoid surgery. About 164 patients with stage II to IVa esophageal squamous cell carcinoma will receive one of two drug combinations plus radiation. If the cancer disappears completely, they continue on camrelizumab alone; if not, they proceed to surgery followed by camrelizumab. The goal is to see if this approach can preserve the esophagus while controlling the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab (an immunotherapy drug) combined with chemotherapy (albumin-bound paclitaxel, carboplatin, or capecitabine) and radiotherapy
- What this could lead to
- If successful, this approach could allow many patients with advanced esophageal cancer to avoid surgery and keep their esophagus, while still controlling the disease.
- What could go wrong
- This is a Phase 2 trial with only 164 participants, so results are preliminary. The combination may cause significant side effects, and not all patients will respond—some may still need surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 164 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age ≥18 years old; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC); 3. Patients with locally advanced resectable stage II/III/IVa (cT1b-4aN0-3M0) ESCC; 4. Have not received chemotherapy, radiotherapy, or surgical treatment for esophageal cancer; 6. ECOG performance status: 0-1; 7. Expected survival ≥12 weeks; 8. Within 7 days prior to enrollment, the participant's blood routine and biochemical indicators meet the following criteria: 1. Hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; platelets ≥100 × 10\^9/L (patients must not have received blood transfusion or growth factor support within 14 days before blood sampling); 2. ALT and AST ≤2.5 times the upper limit of normal (ULN); ALP ≤2.5 times ULN; 3. Total serum bilirubin \<1.5 times ULN (patients with Gilbert's syndrome may enroll if total bilirubin \<3 times ULN); 4. Serum creatinine \<1.5 times ULN or estimated glomerular filtration rate ≥60 ml/min/1.73 m²; 5. Serum albumin ≥30 g/L; 6. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is on anticoagulant therapy and PT value is within the expected therapeutic range; 7. Activated partial thromboplastin time (APTT) ≤1.5 times ULN. 9. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%). 10\. Women of childbearing potential must agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after the study; must have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding; men must agree to use contraceptive measures during the study and for 6 months after the study. 11\. No severe comorbidities that would result in a life expectancy of less than 5 years. 12\. Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: * 1\. Individuals allergic to the treatment drugs; 2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 3. Active or uncontrolled severe infection (≥ CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infection complications, bacteremia, or severe pneumonia, or unexplained fever \>38.5°C before the first administration; 4. Individuals with a history of mental drug abuse who cannot quit or have psychiatric disorders; 5. Subjects who have had or currently have other malignancies requiring active treatment within the past 5 years (fully treated cases with an expected 5-year survival \>90%, such as basal cell or squamous cell skin cancer, cervical carcinoma in situ, or breast carcinoma in situ, are excluded from this restriction); 6. Uncorrectable coagulation disorders; 7. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure NYHA class ≥2; ventricular arrhythmias requiring drug treatment (including QTc interval ≥450 ms for men, ≥470 ms for women); left ventricular ejection fraction (LVEF) \<50%; 8. Severe liver disease (such as cirrhosis), kidney disease, respiratory system disease, uncontrolled diabetes, or other types of systemic diseases; 9. Patients whose imaging shows the tumor has invaded major blood vessels, or for whom the investigator judges that the tumor is highly likely to invade major blood vessels during the study period and cause fatal bleeding; 10. Presence of active autoimmune disease or immunodeficiency, or the following history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc. The following exceptions apply: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be enrolled. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study. 11\. Patients who are using immunosuppressive agents or systemic corticosteroid therapy for immunosuppression purposes (dose \>10 mg/day of prednisone or other equivalent steroids, and continued use within 2 weeks prior to enrollment); 14. Underwent surgery within 28 days before enrollment in this study (excluding biopsy) or whose surgical incision has not fully healed; 15. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent; 16. Pregnant women (positive pregnancy test before taking the drug) or women who are breastfeeding; 17. Patients deemed unsuitable for enrollment based on the investigator's judgment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Late-stage resectable esophageal squamous carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITINGLuoyang, Henan, 471000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.